Actively Recruiting

Age: 21Years +
All Genders
NCT04658628

Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

Led by University of California, Los Angeles · Updated on 2025-10-02

42

Participants Needed

1

Research Sites

353 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.

CONDITIONS

Official Title

Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 21 years of age or older at time of consent
  • Recommended to undergo a spinal cord stimulation trial for chronic back pain by a pain management physician
  • Chronic low back pain lasting 12 weeks or longer despite prior treatments
  • Signed valid Institutional Review Board (IRB)-approved informed consent form
Not Eligible

You will not qualify if you...

  • Women who are not using adequate contraception, are pregnant, breastfeeding, or plan to become pregnant during the study
  • Previous spinal cord stimulation trial or current implant of active devices for pain or cardiac conditions (e.g., pacemaker, defibrillator, drug pump)
  • Current abuse of alcohol or illicit drugs
  • Contraindications to MRI or requirement for repeated body MRIs
  • Presence of implanted devices such as cardiac pacemakers, intracranial implants, aneurysm clips, shunts, cochlear implants, or other stimulators

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California Los Angeles

Los Angeles, California, United States, 90067

Actively Recruiting

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Research Team

M

Meskereen Tolossa

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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